Clinical Trial: A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia
Study Status: Completed
Recruit Status: RECRUITING
Condition: Hemophilia
Study Type: INTERVENTIONAL
Official Title: A Phase 3, Single-arm, Multicenter, Multinational, Open-label, One-way Crossover Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged ? 12 Years With Severe
Brief Summary:
This is a multicenter, multinational, open-label, one-way cross-over, Phase 3, single-arm study for treatment of hemophilia.The purpose of this study is to measure the frequency of treated bleeding episodes with fitusiran in male adult and adolescent (?12 years old) participants with hemophilia A or B, with or without inhibitory antibodies to factor VIII or IX who have switched from their prior standard of care treatment.The total study duration will be up to approximately 50 months (200 weeks, 1 study month is…
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